MAHA & FDA Reform: What It Means for Food Packaging Inks

The Make America Healthy Again (MAHA) initiative, launched under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., signals a significant shift in how the U.S. Food and Drug Administration (FDA) regulates chemicals in food and food packaging. The initiative is part of a broader federal effort to address chronic disease and environmental exposures, particularly among children.

MAHA and the Push for Packaging Reform

MAHA initiative is doing more than just pushing for healthier food choices and reduced reliance on certain food additives. It is likely to impact the food packaging industry as well. RFK Jr. isn’t just looking to be a sitting head of the FDA, he’s “interested in a revolution.” RFK Jr. recently addressed a group of stakeholders at the Chemicals of Concern Policy Summit regarding the need for collaboration in order to remove “toxic chemicals” from our food. Secretary Kennedy has promised to “use every lever of power that my Agency has, every weapon in the HHS arsenal, to change the regulatory environment.” His remarks echo several key themes outlined in the MAHA Report published by ResearchAmerica, which outlines the federal government’s public health goals and the role of chemical safety reform.

Key Regulatory Changes Under MAHA That May Impact Food Packaging

Based on official documents and early policy statements, four major regulatory changes are expected to impact the food packaging and ink industries.

1. Reform of GRAS (Generally Recognized As Safe) Determinations
   The concept of GRAS substances originates from the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. This amendment required that any substance added to food must undergo FDA review—unless it is generally recognized, by qualified experts, as safe under its intended use. These GRAS substances were exempt from the otherwise mandatory premarket approval process.

   Initially, the FDA maintained a formal GRAS affirmation process, where companies could petition the agency to affirm a substance’s GRAS status. However, this process was resource-intensive and slow.

   In 1997, the FDA proposed a major shift: replacing the affirmation process with a GRAS notification system. Under this system, companies can voluntarily notify the FDA of their GRAS determinations. The FDA reviews these notices and may comment, but it does not formally approve or endorse them.

   The spirit of GRAS lies in scientific consensus and transparency, offering a streamlined path for safe ingredients while maintaining a layer of oversight.

   The FDA is proposing to eliminate the self-affirmed GRAS pathway, which currently allows companies to determine a substance’s safety without FDA review. Under MAHA, all food contact substances—including those in adhesives, coatings, and printing inks—will require FDA oversight. However, this directive is not yet legally binding. The FDA must still go through a formal rulemaking process, which includes public notice and comment, before any changes can take effect.

   Secretary Kennedy’s announcement has no immediate legal effect on the status of ingredients currently marketed as GRAS. Until the FDA completes its regulatory process—or Congress enacts new legislation—companies may continue to self-determine GRAS status without notifying the agency.

2. Post-Market Chemical Review Program 
   A new post-market review system would re-evaluate previously approved substances, especially those used in legacy materials. This reflects growing concern that older approvals may not align with current toxicological science. As part of this effort, the agency is expected to apply increased scrutiny to certain chemicals, prioritizing those that pose the greatest potential health risks. This could result in faster reviews and regulatory action for high-priority substances, while others may undergo more extended evaluations.

   In addition to reassessing older approvals, the FDA is working to integrate modern scientific methods and data into its safety assessments. This shift may lead to the adoption of stricter safety standards, particularly for materials that come into contact with food. For the packaging industry, this means more rigorous evaluations and potentially greater pressure to identify and transition to safer alternatives. Companies may need to invest in research and development to stay ahead of evolving regulatory expectations and ensure continued compliance.

3. Expanded Toxicological Assessments
   Toxicity reviews will now include endocrine disruption and neurobehavioral endpoints. While printing inks are not direct food additives, they may migrate into food, making them subject to these expanded evaluations.

4. Manufacturers can proactively respond by adopting low-migration solutions, like INX’s Low Migration Inks & Coatings, which are specifically developed to minimize the risk of chemical transfer in food packaging applications.

5. Cumulative and Mixture Exposure Reviews
   The FDA plans to assess the combined effects of multiple chemicals across the food system. This includes interactions between food additives, packaging materials, and environmental contaminants—an area where scientific models are still evolving.

   To help limit potential chemical interactions and support regulatory readiness, packaging developers can explore gas barrier coatings that act as functional layers, minimizing migration and extending shelf life.

6. While the MAHA initiative is grounded in public health concerns, some experts have raised questions about the scientific rigor behind certain proposals. A recent review by the Center for Health Law and Policy Innovation noted that while many MAHA priorities are supported by science, others may reflect misinterpretations or overextensions of existing research.

   The initiative’s emphasis on terms like “toxic” and “chemical-free” aligns with consumer sentiment but may blur the distinction between hazard and risk, a foundational concept in toxicology.

Industry Implications and Next Steps

The packaging and ink industries should prepare for: 

• Stricter compliance requirements
• More rigorous toxicological data demands
• Potential reformulation of materials

Companies are encouraged to engage proactively with regulators, provide robust migration and exposure data, and advocate for science-based policymaking that distinguishes between theoretical hazards and real-world risks.

Many are turning to sustainable, compliant ink systems, such as INXhrc™ natural-based Rigid Container inks, certified food-and beverage-safe and optimized for low-migration applications, to simplify the transition under MAHA.

For further guidance on practical compliance strategies, INX offers 5 tips for safer food packaging and ink use, covering design, testing, and material selection under modern safety expectations.

The MAHA initiative represents a paradigm shift in FDA oversight of food-contact materials. While the goals of protecting public health and reducing chronic disease are widely supported, the success of these reforms will depend on their scientific integrity, regulatory clarity, and practical implementation.